Why choosing Qualitätsplan?


...because we know how!

How we do it


We come straight to the point. We work:

  • customer-oriented
  • reliable
  • structured
  • pragmatic
  • self-reliant
  • with a short familiarization period
  • by making individual offers for each customer’s need
  • by having a high internal quality standard

What we do


Testing Laboratory

We do:

  • Test planning
  • Verification of product requirements
  • Safety and performance testing according to applicable standards (e.g.: IEC 60601-1 and its particular standards)
  • Reliability testing
  • Summary Reports

Technical Documentation

We compile complete Technical Documentation files including for instance:

  • Specifications
  • Risk Management Files and Analysis
  • Usability engineering files
  • Verification and Validation Plan and Reports
  • Summary Reports
  • Conformity Assessments for MDD and MDR
  • Post Market Plans (PMS, PMCF...)

Compliance Engineering

We help our customer to develop a compliant medical device. Therefore we compile:

  • Complete safety concepts (including, electrical, mechanical and fireprevending concepts)
  • Design reviews
  • Insulation diagrams etc.

Don't hesitate to contact us!